PENGELOMPOKAN OBAT TRADISIONAL

FITOFARMAKA

OBAT HERBAL TERSTANDAR

Keamanan dan
Kemanfaatan
dibuktikan secara
Keamanan dan ilmiah melalui uji
JAMU Kemanfaatan klinik
dibuktikan secara
❑Standardisasi bahan baku & produk
ilmiah melalui uji jadi
pra klinik ❑Serifikat CPOTB
Keamanan dan
❑Standardisasi Bahan Baku & ❑Uji Pra Klinik
Kemanfaatan
produk jadi ❑Uji Klinik
Data Produk Obat Tradisional
dibuktikan secara ❑Mutu Produk Hingga: Februari 2021
❑Serifikat CPOTB
empiris
❑Uji Pra Klinik (Toksisitas dan Sumber: http://cekbpom.pom.go.id/
Farmakodinamika)
❑Mutu Produk Klasifikasi Jamu OHT FF
Bukti Ilmiah
Jumlah >11000 74 25
Traditional vs Western Medicine Philosophy

• Traditional • Western Medicine

• Inductive and Synthetic • Reductive and analytical

• Individualized • Standardized
• Experience-based • Evidenced-based
• Summary of clinical observations • Result of laboratory
• Emphasizes the the role of body in
experimentations
healing • Mainly relies on medications and
procedures
• Herbs and natural agents
• Pure chemical compounds
• Behavior of the system as a whole
• Structure and function of the parts
• Maintains health
• Manages disease
 Redacid (DLBS2411) Comparison with PPIs
Percent of time of 24-h period with intragastric pH > 4
after an oral single dose administration

D. Pantoflickova et al.
Aliment Pharmacol Ther 2003

Murdani et al (DLBS2411-0111) 2013

Percent of time of 24-h period with intragastric pH > 4

Ndraha, S. Medicinus 32(3): 8-15., 2019
Inlacin (DLBS3233) Reduces HbA1c level
HbA1c HbA1c reduction from baseline (6 wk of
treatment)
11.00
0.20 0.08
10.50
0.00

HbA1c reduction (%)

10.27

HbA1c level (%)

10.00 -0.20 PLC D50
-0.40
9.58 PLC
9.50 9.50 -0.60
D50 D-HbA1c 6 wk
9.13 -0.80
9.00 -1.00
-1.20
8.50 -1.13
-1.40
8.00 -1.60
B-HbA1c E-HbA1c Group

Diabetes Complication Complication Risk Reduction

Diabetes-related death 21%
Myocardial Infarction 14%
Stroke 12%
Peripheral vascular disease 43%
Microvascular diseases 37%
Heart Failure 16%
 6

Pain in the stomach Breast Pain Back Pain

Headache
Dari penelitian ini didapatkan bahwa efektivitas dari DLBS1442
(Predimenol) dapat meringankan simptom nyeri yang disebabkan oleh PMS
dimana secara keseluruhan menunjukkan VAS score yang lebih rendah
setelah diberikan DLBS1442

Tjandrawinata RR, et al. Symptomatic treatment of premenstrual syndrome and/or primary

dysmenorrhea with DLBS1442, a bioactive extract of Phaleria macrocarpa. International Journal of
General Medicine 2011:4 465– 476
Method:
• Ten endometriosis and adenomyosis patients were chosen consecutively at Yasmin Clinic Dr. Cipto Mangunkusumo Jakarta from January to March
2013.
• Patients with a VAS value> 4 were given DLBS1442 at a dose of 2-3 x100 mg for 12 weeks and reassessed the pain scale for the next 3 consecutive
menstrual cycles.
Parameter:
The patient's pain scale (before and during menstruation, dysmenorrhoea, dysentery and dysuria) was assessed using the Visual
Analog Score (VAS).
 ❑

Adverse
events of ❑

herbal ❑

products ❑
❑

WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems, 2004